510(k) · Cleared
ClearedFemoral Trochanteric Nail System – Neonail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoortho Produtos Ortopédicos S/A · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 6, 2022 as substantially equivalent to K200869 (Stryker Trauma GmbH, 2020) and 1 other predicate after a 244-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Dec 6, 2022
- Review
- 244 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K970097 (1997). 53 ancestors in all, the oldest K871539 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 5 generations between
- 3 generations backK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- 2 generations backK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- 1 generation backK200869 Gamma3 SystemStryker Trauma GmbH · 2020
- This deviceK221021 Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A · 2022
Show all 9 generations
- Root · 9 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 8 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 7 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 6 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 5 generations backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- 4 generations backK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
- 3 generations backK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
- 2 generations backK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
- 1 generation backK200869 Gamma3 SystemStryker Trauma GmbH · 2020
- This deviceK221021 Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −8 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −7 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −6 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −5 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| −4 | K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN… | Stryker Trauma GmbH | 2018 | — |
| −3 | K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System… | Stryker Trauma GmbH | 2018 | — |
| −2 | K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System… | Stryker Trauma GmbH | 2019 | — |
| −1 | K200869 | Gamma3 System | Stryker Trauma GmbH | 2020 | — |
| 0 (this device) | K221021 | Femoral Trochanteric Nail System – Neonail | Neoortho Produtos Ortopédicos S/A | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200869 | Gamma3 SystemSummary page 5…ject device Femoral Trochanteric Nail System – Neonail has the following differences regarding the INDICATIONS FOR USE when compared with the predicate device cleared in K200869: The subject device is not indicated in cases including osteoporotic and osteopenic bone; The subject device… | 2020 |
| * | K141103 | Intramedullary Nail and Screws-NeonailSummary page 5…Device Name Predicate K200869 Stryker Orthopaedics Gamma®3 Nail System Primary K141103 Neoortho Produtos Ortopédicos Intramedullary Nail and Screws - NEONAIL Additional Femoral Trochanter… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 26 of the 53 ancestors have a recall of any class.
- 5 other devices also cite its predicate K200869.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The Femoral Trochanteric Nail System – Neonail is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221021: Femoral Trochanteric Nail System – Neonail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221021
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026